Mycophenolate mofetil Normon 250 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Myfortic 250 mg enteric-coated tablets EFG

(mycophenolate mofetil)

Package leaflet contents

1. What Micofenolato mofetilo Normon is and what it is used for
2. What you need to know before taking Micofenolato mofetilo Normon
3. How to take Micofenolato mofetilo Normon
4. Possible side effects
5. How to store Micofenolato mofetilo Normon
6. Contents of the pack and other information

1. What Micofenolato mofetilo Normon is and what it is used for

Micofenolato mofetilo tablets are used to prevent the body from rejecting a transplanted kidney, heart, or liver. It is a medicine called an immunosuppressant, used to prevent organ transplant rejection by reducing the activity of the immune system.

This medicine is used in combination with other medicines known as cyclosporine and corticosteroids.

2. What you need to know before starting to take Mycophenolate mofetil Normon

WARNING

Mycophenolate causes birth defects and miscarriages. If you are a woman who could become pregnant, you must have a negative pregnancy test before starting treatment and must follow your doctor's advice on contraception.

Your doctor will explain and provide you with written information, particularly about the effects of mycophenolate on unborn babies. Read this information carefully and follow the instructions.

If you do not fully understand these instructions, please consult your doctor again for further explanation before taking mycophenolate. See further information below in this section under the headings “Warnings and precautions” and “Pregnancy and breastfeeding”.

Do not take Mycophenolate mofetil Normon:

• If you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid, or any of the other ingredients of this medicine (listed in section 6).
• If you are a woman who could become pregnant and have not had a negative result on a pregnancy test before the first prescription, as mycophenolate may cause birth defects and miscarriages.
• If you are pregnant or intend to become pregnant, or think you might be pregnant.
• If you are not using effective contraception (see Pregnancy and breastfeeding).
• If you are breastfeeding.

Do not take this medicine if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking Mycophenolate mofetil Normon.

? Warnings and precautions

Consult your doctor immediately before taking Mycophenolate mofetil Normon:

• If you experience any signs of infection (e.g. fever, sore throat), unexplained bruising and/or unexpected bleeding, as this medicine, by suppressing your immune system, may make you more susceptible to infections than usual, such as infections of the skin, mouth, respiratory tract, stomach and intestine, lungs, and urinary tract.
• If you have or have had any digestive system problems in the past, for example, stomach ulcer.
• If you plan to become pregnant, or if you become pregnant during treatment with this medicine.

If any of the above apply to you (or if you are unsure), consult your doctor immediately before taking this medicine.

Effect of sunlight

This medicine reduces your body's defences. For this reason, there is an increased risk of developing skin cancer. Limit your exposure to sunlight and UV light by:

• Wearing appropriate protective clothing that also covers your head, neck, arms, and legs
• Using a sunscreen with a high sun protection factor.

? Taking Mycophenolate mofetil Normon with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription, and herbal medicines. This is because this medicine may affect how other medicines work. Other medicines may also affect how Mycophenolate mofetil Normon works. In particular:

• Medicines containing azathioprine or other immunosuppressants (sometimes given after transplant surgery),
• cholestyramine (used to treat high cholesterol levels),
• rifampicin (an antibiotic used to prevent and treat infections such as tuberculosis (TB)),
• antacids or proton pump inhibitors (for stomach acidity problems such as indigestion),
• phosphate binders used in patients with chronic renal failure to reduce phosphate absorption in the blood.

Vaccines: If you need to receive a vaccine (especially live organism vaccines) during treatment with this medicine, consult your doctor or pharmacist. Your doctor will advise you on which vaccines may be suitable.

You must not donate blood during treatment with this medicine and for at least 6 weeks after stopping treatment. Men must not donate semen during treatment with this medicine and for at least 90 days after stopping treatment.

? Taking Mycophenolate mofetil Normon with food and drinks

Taking food and drinks does not affect your treatment with this medicine.

? Pregnancy, fertility and breastfeeding

Contraception in women taking Mycophenolate mofetil Normon

If you are a woman who could become pregnant, you must always use two effective methods of contraception. This includes:

• Before starting to take this medicine
• Throughout treatment with this medicine
• Up to 6 weeks after stopping this medicine

Consult your doctor to determine which contraceptive method is most suitable for you. This will depend on your personal situation. The use of two contraceptive methods is recommended, as this reduces the risk of unintended pregnancy. Consult your doctor as soon as possible if you think your contraceptive method may not have been effective or if you have missed taking your contraceptive pill.

You are considered not able to become pregnant if you meet any of the following criteria:

• You are post-menopausal, i.e., you are at least 50 years old and your last menstrual period occurred more than one year ago (if your periods have stopped due to cancer treatment, you may still be able to become pregnant)
• You have had both fallopian tubes and both ovaries surgically removed (bilateral salpingo-oophorectomy)
• You have had your uterus surgically removed (hysterectomy)
• Your ovaries do not function (premature ovarian failure confirmed by a specialist gynaecologist)
• You were born with one of the following rare conditions that make pregnancy impossible: XY genotype, Turner syndrome, or uterine agenesis
• You are a girl or adolescent who has not yet started menstruating

Contraception in men taking Mycophenolate mofetil Normon

Available evidence does not indicate an increased risk of birth defects or miscarriage if the father takes mycophenolate. However, the risk cannot be completely excluded. As a precautionary measure, you or your female partner are advised to use a reliable method of contraception during treatment and for up to 90 days after stopping this medicine.

If you are planning to have a child, consult your doctor about possible risks.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before taking this medicine. Your doctor will discuss with you the risks and alternative treatments available to prevent rejection of the transplanted organ if:

• You intend to become pregnant.
• You have missed a period or think you may have missed a menstrual period, or have unusual menstrual bleeding, or suspect you may be pregnant.
• You have had sexual intercourse without using an effective contraceptive method.

If you become pregnant during treatment with mycophenolate, inform your doctor immediately. However, continue taking Mycophenolate mofetil until you see your doctor.

Pregnancy

Mycophenolate mofetil causes a very high frequency of miscarriages (50%) and serious harm to the unborn baby (23–27%). Reported malformations include abnormalities of the ears, eyes, face (cleft lip and palate), finger development, heart, oesophagus (the tube connecting the throat to the stomach), kidneys, and nervous system (e.g. spina bifida (where the bones of the spine do not develop properly)). Your baby may be affected by one or more of these.

If you are a woman who could become pregnant, you must have a negative pregnancy test result before starting treatment and must follow your doctor’s contraception advice. Your doctor may require more than one pregnancy test to confirm you are not pregnant before starting treatment.

Breastfeeding

Do not take this medicine if you are breastfeeding. This is because small amounts of the medicine may pass into breast milk.

? Driving and using machines

This medicine is unlikely to affect your ability to drive or operate machinery.

Mycophenolate mofetil Normon contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; hence, it is essentially “sodium-free”.

3. How to take Mycophenolate mofetil Normon

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist.

Dosage

The dose you should take depends on the type of transplant you have received. The usual doses are shown below. Treatment will continue as long as necessary to prevent rejection of the transplanted organ.

Kidney transplant

Adults: The first dose should be administered within 72 hours after the transplant surgery. The recommended daily dose is 8 tablets (2 g of active ingredient), given in two divided doses. This means taking 4 tablets in the morning and 4 tablets in the evening.

Children (between 2 and 18 years of age): The dose varies depending on the child's size. Your doctor will determine the most appropriate dose based on body surface area (weight and height). The recommended dose is 600 mg/m2, administered twice daily.

Heart transplant

Adults: The first dose should be administered within 5 days after the transplant surgery. The recommended daily dose is 12 tablets (3 g of active ingredient), given in two divided doses. This means taking 6 tablets in the morning and 6 tablets in the evening.

Children: There are no data available to recommend the use of this medicine in children who have received a heart transplant.

Liver transplant

Adults: The first dose should be administered at least 4 days after the transplant surgery and once you are able to swallow oral medication. The recommended daily dose is 12 tablets (3 g of active ingredient), given in two divided doses. This means taking 6 tablets in the morning and 6 tablets in the evening.

Children: There are no data available to recommend the use of this medicine in children who have received a liver transplant.

How to take this medicine

Swallow the tablets whole with a glass of water. Do not break or crush them.

If you take more Mycophenolate mofetil Normon than you should

If you take more Mycophenolate mofetil Normon than you should, consult your doctor or go to the hospital immediately. Do this also if someone accidentally takes your medicine. Take the medicine packaging with you.

If you forget to take Mycophenolate mofetil Normon

If you forget to take a dose, take it as soon as you remember. Then continue taking it at your usual times. Do not take a double dose to make up for forgotten doses.

If you stop taking Mycophenolate mofetil Normon

Do not stop taking this medicine unless your doctor tells you to. If you interrupt treatment, the risk of rejection of the transplanted organ may increase.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can have adverse effects, although not everyone gets them.

Consult your doctor immediately if you notice any of the following serious adverse effects, as you may need urgent medical treatment:

• if you have symptoms of infection such as fever or sore throat
• if you develop bruises or unexpected bleeding
• if you develop a rash, swelling of the face, lips, tongue or throat, with difficulty breathing. You may be experiencing a severe allergic reaction to the medicine (such as anaphylaxis, angioedema).

Common problems

Some of the more common problems include diarrhea, decreased number of white or red blood cells in the blood, infections, and vomiting. Your doctor will carry out regular blood tests to monitor for any changes:

• in the number of blood cells or changes in
• blood levels of substances such as sugar, fat or cholesterol.

The occurrence of adverse effects is more likely in children than in adults. These include diarrhea, infections, and decreased white and red blood cells in the blood.

Fighting infections

Treatment with mycophenolate mofetil reduces the body's defenses. This is to prevent transplant rejection. For this reason, the body also cannot fight infections as effectively as under normal conditions. This means you may get more infections than usual. These include infections affecting the brain, skin, mouth, stomach and intestines, lungs, and urinary system.

Skin and lymphatic cancer

As with patients treated with other immunosuppressants, a very small number of patients treated with this medicine have developed cancers of lymphoid tissues and skin.

General unwanted effects

General adverse effects affecting the whole body may occur. These include severe allergic reactions (such as anaphylaxis, angioedema), fever, feeling very tired, difficulty sleeping, pain (such as stomach pain, chest pain, joint or muscle pain, pain when urinating), headache, flu-like symptoms, and swelling.

Other adverse reactions may include:

Skin problems such as: acne, cold sores, shingles, skin growths, hair loss, skin rash, itching.

Urinary problems such as: kidney problems or frequent need to urinate.

Digestive system and mouth problems such as: constipation, feeling unwell (nausea), indigestion, loss of appetite, flatulence, inflammation of the pancreas, colon or stomach, intestinal disorders including bleeding, liver problems, swollen gums, and mouth ulcers.

Nervous system problems such as: dizziness, drowsiness or numbness, seizures, tremor, vertigo, muscle spasms, feelings of anxiety or depression, changes in mood or thinking.

Heart and blood vessel problems such as: changes in blood pressure, abnormal heartbeat, and dilation of blood vessels.

Lung problems such as: pneumonia, bronchitis, breathing difficulties, cough, which may be due to bronchiectasis (a condition in which the airways are abnormally widened) or pulmonary fibrosis (scarring of the lung). Consult your doctor if you develop a persistent cough, shortness of breath, fluid in the lung/thoracic cavity, or sinus problems.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Mycophenolate mofetil Normon

Store below 30°C. Keep in the original packaging.

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Mycophenolate Mofetil Normon

The active substance is mycophenolate mofetil. Each tablet contains 250 mg of mycophenolate mofetil.

The excipients are:

Core: microcrystalline cellulose (E-460), povidone (E-1201), sodium croscarmellose, magnesium stearate (E-470b).

Coating: indigo carmine lake (E-132), red iron oxide (E-172), hypromellose (E-464), titanium dioxide (E-171), and macrogol 6000.

Appearance of Mycophenolate Mofetil Normon and pack size

Rosy-colored, round, biconvex tablets.

Each pack contains 100 tablets.

Other presentations:

Mycophenolate mofetil Normon 500 mg film-coated tablets EFG.

Marketing Authorization Holder and Manufacturer Responsible

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 ­ 28760 Tres Cantos ­ Madrid (SPAIN)

Date of revision of this leaflet: March 2018

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/.